1. 1 US Investigator Meeting DIAS-4, Chicago, July 2011 Good Clinical Practice (GCP) for Investigators and the Research Team

2. US Investigator Meeting DIAS-4, Chicago, July 2011 2 What kind of audit findings 1.Lack of information in medical record 2.Enrolment of patients who violate the exclusion or do not fulfil the inclusion criteria 3.Unreported AEs in the CRF 4.Lack of time for the Principal Investigator to perform the trial 5.Investigator signed Informed Consent before the patient 6.Failure of the site to complete and maintain the IMP records

3. US Investigator Meeting DIAS-4, Chicago, July 2011 3 GCP ensures that: Patients rights, safety, and well-being are protected Clinical trials are based on good science, are well designed and properly analysed The study procedures are properly undertaken and documented Why follow GCP? If GCP is not followed: The patients could be exposed to unnecessary risks The data collected may be unreliable The clinical trial can be rejected

4. US Investigator Meeting DIAS-4, Chicago, July 2011 4 Agenda GCP responsibility for Investigator and Research team The 12 Golden GCP rules Question & answer

5. US Investigator Meeting DIAS-4, Chicago, July 2011 5 Rule number 1 Know and Follow the Study Protocol Read it Agree it Sign it Follow It Make it available File it

6. US Investigator Meeting DIAS-4, Chicago, July 2011 6 Rule number 2 Select, train and log your study personnel Investigators CVs Keep people informed Log of study personnel

7. US Investigator Meeting DIAS-4, Chicago, July 2011 7 Example of the Log of Study Personnel

8. US Investigator Meeting DIAS-4, Chicago, July 2011 8 Rule number 3 Record Data Carefully Complete… timely, correctly, all required data Avoid… missing data Date and initial (we use eCRF: PASSWORD)…

9. US Investigator Meeting DIAS-4, Chicago, July 2011 9 Rule number 4 Ensure that you study equipments are adequate Suitable… Calibrated and Checked… Available… Maintained… = SCAM

10. US Investigator Meeting DIAS-4, Chicago, July 2011 10 Rule number 5 Maximise your patients protection IRB approval Informed Consent (IC)

11. US Investigator Meeting DIAS-4, Chicago, July 2011 11 Patient and investigator signed on the respective part of the IC but did not date and time. The study coordinator noticed this and dated it on behalf of the investigator and the patient. Is this correct according to GCP? Case 1 - Consent No, this is non-compliant with GCP – Investigator and patient (or witness or legal representative) must personally sign and date and time the informed consent.

12. US Investigator Meeting DIAS-4, Chicago, July 2011 12 Can a study coordinator take informed consent? Case 2 - Consent In Lundbeck studies, the study coordinator can take part in the discussion with the patient about the study and the patient information sheet - but the investigator must always be involved and only the investigator can obtain the Informed Consent.

13. US Investigator Meeting DIAS-4, Chicago, July 2011 13 Rule number 6 Predict accurately and log your patient recruitment Select the right patients (in and exclusion criteria) If a patient decides to withdraw try to obtain and record the reason if possible Keep the patients listed in logs

14. US Investigator Meeting DIAS-4, Chicago, July 2011 14 Rule number 7 Thorough documentation of study drug flow Storage at site according to requirements Document receipt, administration, storage, and return of study drug If IMP was stored outside temperature limits – even for a minimum period of time – contact your monitor immediately

15. US Investigator Meeting DIAS-4, Chicago, July 2011 15 Rule number 8 Ensure timely and efficient safety reporting Adverse Event (AE) Serious Adverse Event (SAE)

16. US Investigator Meeting DIAS-4, Chicago, July 2011 16 Rule number 9 Ensure the quality of laboratory evaluations Laboratory results and requests CT or MRI scan

17. US Investigator Meeting DIAS-4, Chicago, July 2011 17 Rule number 10 Maintain good trial files and archives If it is not documented, it doesn't exist! Storage of the documentation

18. US Investigator Meeting DIAS-4, Chicago, July 2011 18 Rule number 11 Maximise data quality Monitoring by CRA Medical notes Source Data Identification form

19. US Investigator Meeting DIAS-4, Chicago, July 2011 19 Source Document Identification Site no.: H. Lundbeck A/S Principal Investigat or: Please complete the form by marking (one tick) of where the first place of the clinical trial data will be entered first (source documents). Date and result of:CRF Patients medical record/ notes Other source - please specify (e.g. nurses notes) Patient identification Date of visit Informed Consent Please complete the form by marking (one tick) where of the clinical trial data will be entered first X X X

20. US Investigator Meeting DIAS-4, Chicago, July 2011 20 Rule number 12 Keep everyone fully informed Patient and Caregiver EC Sponsor SAE reporting Study research team CRA

21. US Investigator Meeting DIAS-4, Chicago, July 2011 21 GCP ensures that: Patients rights, safety, and well-being are protected Clinical trials are based on good science, are well designed and properly analysed The study procedures are properly undertaken and documented Keep the number of audits findings down Q and A

22. US Investigator Meeting DIAS-4, Chicago, July 2011 22 GCP Definitions Gun Control PanelGateway Control Protocol Gods Child Project Grand Central Partnership Great Circus Parade Ground Control Position Ground Control Planning Green City Project Great-Circle Path Grand Central Parkway Thank you! Good Clinical Practice